Effectiveness of Oscillation on Postoperative Pulmonary Complications After Elective Postcardiac Surgery

NCT ID: NCT06902220

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 470 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-01-31

Brief Summary

Our study aims to evaluate the effectiveness of continuous high-frequency oscillation therapy in reducing PPCs in patients following elective cardiac surgery. Through a prospective, multicenter, randomized controlled trial, we seek to establish evidence that could lead to improved postoperative pulmonary care and outcomes for cardiac surgery patients.

Conditions

Postoperative Pulmonary Atelectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Once patients' CPOT score reaches 0, intubated patients will receive continuous high-frequency oscillation (CHFO) therapy three times daily, with 8-hour intervals and 10-minute sessions. Extubated patients will receive CHFO and continuous positive expiratory pressure (CPEP) therapy twice daily, with 12-hour intervals and 10-minute sessions.

Group Type: EXPERIMENTAL

continuous high-frequency oscillation therapy

Intervention Type: DEVICE

Once patients' CPOT score reaches 0, intubated patients will receive continuous high-frequency oscillation (CHFO) therapy three times daily, with 8-hour intervals and 10-minute sessions. Extubated patients will receive CHFO and continuous positive expiratory pressure (CPEP) therapy twice daily, with 12-hour intervals and 10-minute sessions.

Control group

Participants in the control group will only receive standard medical, nursing, and allied healthcare, with daily decisions made without the use of protocols. This includes spontaneous breathing and awakening trials as decided by the attending intensivist, ad hoc management of pain and delirium, and once or twice daily passive and active exercises determined by the physiotherapist, with patients typically remaining in bed if on ventilation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

continuous high-frequency oscillation therapy

Once patients' CPOT score reaches 0, intubated patients will receive continuous high-frequency oscillation (CHFO) therapy three times daily, with 8-hour intervals and 10-minute sessions. Extubated patients will receive CHFO and continuous positive expiratory pressure (CPEP) therapy twice daily, with 12-hour intervals and 10-minute sessions.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patients (18 years or older) undergoing elective cardiac surgery will be included. Participants must provide informed consent upon ICU admission and have at least one risk factor for PPCs, including age ≥ 75 years, American Society of Anesthesiologists (ASA) score ≥ 2, history of chronic obstructive pulmonary disease (COPD) stage ≥ 2 or asthma (moderate to severe), current heavy smoking or heavy smoking history within the past 6 months, obstructive sleep apnea, frailty index > 0.21 or body max index (BMI) ≥ 30 kg/m².

Exclusion Criteria

• Patients will be excluded if they have contraindications for oscillation treatment (e.g., untreated tension pneumothorax); have pneumothorax or air leak syndrome at entry; require more than 2 μg/kg/min of norepinephrine; have been diagnosed with pneumonia within 2 weeks prior to surgery; have refractory arrhythmia at entry; have a left ventricular ejection fraction < 35%; have mean pulmonary artery pressure (mPAP) > 35 mmHg; are postoperative from spinal surgery within the past 2 weeks; require a ventricular assist device; have renal failure requiring continuous renal replacement therapy (CRRT) at entry; are planned for re-operation within 48 hours or have undergone organ transplantation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southeast University, China

OTHER

Sponsor Role: lead

Responsible Party

Jingyuan,Xu

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jingyuan Xu, M.D.

Role: CONTACT

xujingyuanmail@163.com

8602583262550

Other Identifiers

2024ZDSYLL381-Y01

Identifier Type: -

Identifier Source: org_study_id